Ortho8, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2325-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile

Product Classification:

Class II

Date Initiated: July 9, 2021

Date Posted: August 25, 2021

Recall Number: Z-2325-2021

Event ID: 88308

Reason for Recall:

EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

Status: Ongoing

Product Quantity: N/A

Code Information:

All Lots

Distribution Pattern:

US Nationwide distribution in the states of Al, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MO, NC, NV, NJ, NY, OK, PA, SC, TN, TX, UT, VA.

Voluntary or Mandated:

Voluntary: Firm initiated